EP1878091A2 - Improved electrical lead for an electronic device such as an implantable device - Google Patents
Improved electrical lead for an electronic device such as an implantable deviceInfo
- Publication number
- EP1878091A2 EP1878091A2 EP06759133A EP06759133A EP1878091A2 EP 1878091 A2 EP1878091 A2 EP 1878091A2 EP 06759133 A EP06759133 A EP 06759133A EP 06759133 A EP06759133 A EP 06759133A EP 1878091 A2 EP1878091 A2 EP 1878091A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- electrical wire
- segment
- pairs
- lead
- adjacent segments
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
- A61N1/086—Magnetic resonance imaging [MRI] compatible leads
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/37—Monitoring; Protecting
- A61N1/3718—Monitoring of or protection against external electromagnetic fields or currents
Definitions
- the present invention relates to electrical leads for devices such as, without limitation, implantable devices, and in particular to an electrical lead which resists the induction of currents from an external electromagnetic field and therefore reduces the likelihood of excessive heating from such fields.
- Magnetic resonance imaging is generally regarded as an extremely safe, non invasive diagnostic technique. MRI may, however, pose a threat to patients that have implantable devices, such as, without limitation, a deep brain stimulation (DBS) device, a pacemaker, a neurostimulator, or a cardio defibrillator.
- DBS deep brain stimulation
- a pacemaker pacemaker
- a neurostimulator a neurostimulator
- a cardio defibrillator Currently, patients with metallic implants are not allowed to undergo an MRI scan.
- One of the main reasons for this is the excessive heating caused by the electromagnetic field concentration around the leads of an implant during an MRI procedure.
- the FREEHAND System Implantable Functional Neurostimulator is a commercially available RF-powered motor control neuroprosthesis that consists of both implanted and external components sold by NeuroControl Corporation of Cleveland, OH. Findings from of an MRI-induced heating experiment during which the FREEHAND System was exposed to a whole-body-averaged SAR of 1.1 W/kg for 30 minutes showed that localized temperature increases were no greater than 2.7 0 C with the device in a gel-filled phantom. A patient with a FREEHAND system can thus only undergo an MRI procedure under certain input power levels for a 1.5 Tesla scanner.
- United States Patent No. 6,284,971 discloses a coaxial cable which may be a magnetic resonance imaging coaxial cable designed for enhanced safety so as to reduce the risk of excessive heating or burns to a user.
- the cable has an elongated axially oriented inner conductor and an axially oriented outer shield conductor in spaced relationship with respect thereto with a first dielectric material disposed therebetween.
- high permittivity materials must be employed. This requirement may create flexibility problems since high permittivity materials are brittle and rigid.
- RF chokes and filters have been used in several previous studies. For example, as described in Susil RC 5 et al., "Multifunctional Interventional Devices for MRI: A Combined Electrophysiology/MRI Catheter", MRM 47:594-600 (2002), RF chokes were used in the design of a combined electrophysiology/MRI catheter, and as described in Ladd ME, et. al., "Reduction of Resonant RF Heating in Intravascular Catheters Using Coaxial Chokes", MRM 43:615-619 (2000), triaxial chokes were used to present a high impedance to currents flowing on the outer surface of the triax.
- United States Patent No. 6,539,253 discloses an implantable medical device incorporating integrated circuit notch filters
- United States Patent No. 5,817,136 discloses a pacemaker with EMI protection. Both of the designs ensure electromagnetic interference is not a problem, however safety in terms of heating is not guaranteed. High current may still be flowing through long cables and these high currents may cause excessive heating and buns.
- United States Patent No. 5,217,010 describes optical signal transmission in between the generator and the organ in a pacemaker, which provides safety since there is no coupling with the optical system and the electromagnetic field.
- the electrical to optical and optical to electrical energy conversion efficiency is limited and therefore the lifetime of the pulse generator is reduced significantly. Miniaturization in this case is also a difficult task.
- an electrical lead which may be used with, for example, metallic implants, which resists the induction of currents from an external electromagnetic field, such as the field that is present during MRI scanning, and therefore reduces the likelihood of excessive heating from such fields.
- the invention relates to lead for an electronic device which resists the induction of a current from an electromagnetic field external to the lead, as may be present during an MRI process.
- the lead includes one or more pairs of adjacent segments of electrical wire, each of the pairs including a first segment of electrical wire and a second segment of electrical wire.
- the adjacent segments of electrical wire may be single conductor electrical wires or multiple conductor electrical wires.
- the lead also includes one or more shielded RF chokes, wherein each of the shielded RF chokes is provided between the first segment of electrical wire and the second segment of electrical wire of a respective one of the one or more pairs of adjacent segments.
- the shielded RF chokes have a first end operatively coupled to the first segment of electrical wire and a second end operatively coupled to the second segment of electrical wire of the respective pair of adjacent segments.
- the one or more pairs of adjacent segments comprises a plurality of pairs of adjacent segments of electrical wire and the one or more shielded RF chokes comprises a plurality of shielded RF chokes.
- the electromagnetic field includes electromagnetic energy having a first wavelength, and the first segment of electrical wire and the second segment of electrical wire in each of the plurality of pairs of adjacent segments of electrical wire each has a length of no more than about a predetermined percentage, such as twenty five percent, of the first wavelength.
- the electronic device may be a device carried by the body of a patient, such as an implantable device.
- the shielded RF chokes may include an inductor covered by one or more layers of conductive shielding material, such as a metallic shielding material.
- a first end of the one or more layers of conductive shielding material is electrically connected to the inductor and a second end of the one or more layers of conductive shielding material is either floating or connected to an insulator.
- each inductor in the shielded RF chokes may include a core, such as a paramagnetic core.
- the shielded RF chokes may comprise toroidal inductors, wherein a coil is wrapped around a doughnut-shaped core.
- one or more electrical shielding layers, such as metallic layers may be provided around the toroidal inductor to provide additional shielding.
- the lead may further include a layer of insulating material covering at least a portion of the one or more pairs of adjacent segments of electrical wire and at least a portion the one or more shielded RF chokes.
- one or more of the one or more shielded RF chokes comprises a first conductor and a first inductor connected in series and provided between the first segment of electrical wire and the second segment of electrical wire of the respective one of the one or more pairs of adjacent segments, at least one layer of conductive shielding material covering the first conductor and the first inductor, and a capacitor provided between the first conductor and the at least one layer of conductive shielding material.
- the invention in yet another embodiment, relates to an apparatus that may be implanted within a patient's body which resists the induction of a current from an electromagnetic field external to the apparatus.
- the apparatus includes a generator for generating one or more electrical pulses, and a lead for delivering the one or more electrical pulses to tissue within the patient's body.
- the lead in the apparatus may be structured according to the various embodiments described above.
- the invention relates to a method of making an implantable device including the various embodiments of the lead described above.
- the method includes providing one or more pairs of adjacent segments of electrical wire, each of the pairs including a first segment of electrical wire and a second segment of electrical wire, and providing a shielded RF choke, as described in the various embodiments above, between the first segment of electrical wire and the second segment of electrical wire of each one of the one or more pairs of adjacent segments.
- Figure 1 is a schematic diagram of an electrical lead according to a first embodiment of the present invention.
- Figure 2 is a schematic diagram showing the electrical lead of Figure 1 being used in an implantable device
- FIGS 3 through 10 are schematic diagrams of various alternative embodiments of an electrical lead according to the present invention.
- Figure 11 shows simulation results for electrical lead according to an embodiment of the invention
- Figure 12 shows a set up for a gel phantom experiment that was performed on a pacemaker including an electrical lead according to an embodiment of the invention
- Figure 13 shows temperature profiles of the gel phantom experiments performed on a pacemaker including an electrical lead according to an embodiment of the invention.
- Figure 1 is a schematic diagram of an electrical lead 5 for an electronic device carried by the body of a patient according to a first embodiment of the present invention.
- patient shall refer to any member of the animal kingdom, including human beings.
- carrier by the body of the patient in reference to as device shall mean that the device may be implanted within the patient body, worn on or attached externally to the patent's body, or some combination thereof.
- the electrical lead 5 shown in Figure 1 forms a part of an implantable device, such as, without limitation, a deep brain stimulation (DBS) device, a pacemaker, a neurostimulator, or a cardio defibrillator, to deliver electrical signals (e.g., electrical pulses) from a generator 15 to a location 20, such as an organ or some other tissue, within the body to which the electrical signals are to be applied (for illustrative purposes, Figure 2 shows a DBS device).
- DBS deep brain stimulation
- the electrical lead 5 allows for safer MRI scanning of patients by decreasing the amount of heating caused by the RF field.
- the electrical lead 5 includes a plurality of segments of electrical wire 25 which, in this embodiment, each comprise a single conductor wire.
- each of the segments of electrical wire 25 comprises a flexible insulated single conductor wire.
- the electrical lead 5 includes a shielded RF choke 30 that is inserted between two adjacent segments of electrical wire 25.
- shielded RF choke shall refer to an inductor that traps an electromagnetic field or fields within a confined area in order to resist the penetration of external electromagnetic fields into the confined area and therefore resist interaction between external electromagnetic fields and with electromagnetic fields that may exist in the confined area.
- the shielded RF choke 30 comprises an inductor 33, in the form of a coil, surrounded by a layer of electrical shielding material 35, such as a metallic shielding material like copper, aluminum, gold, silver or nitinol.
- the layer of shielding material 35 helps to reduce the risk of magnetic coupling during an MRI scanning process.
- a first end of the inductor 33 is electrically coupled to one of the adjacent segments of electrical wire 25 and the opposite end of the inductor 33 is electrically coupled to the other of the adjacent segments of electrical wire 25.
- one end of the layer of conductive shielding material 35 is electrically connected to the inductor 33 and the other end of the layer of conductive shielding material 35 either floats or touches the insulating material, if present, surrounding the electrical wire 25.
- the electrical lead 5 may include multiple adjacent segments of electrical wire 25 and multiple shielded RF chokes 30 connected as shown in Figure 1 and described above.
- the electrical lead 5 includes a length consisting of multiple adjacent segments of electrical wire 25 and multiple shielded RF chokes 30 provided therebetween.
- each segment of electrical wire 25 is substantially shorter than one half of the wavelength of the electromagnetic field with which it is desired to use the electrical lead 5. As will be appreciated, if multiple electromagnetic fields are possible, then the shortest of the wavelengths is chosen for this design parameter.
- each segment of electrical wire 25 is less than or equal to about one quarter of the wavelength ( ⁇ /4) of the electromagnetic field (e.g., the RF field to be used in an MRI scanning process; the most common frequency used in MRI scanning are 64 MHz, although 42 MHz and 128 MHz systems are also common) with which it is desired to use the electrical lead 5.
- the preferred electrical lead 5 may be a conventional lead used for implantable devices that is serially modified to include the shielded RF chokes 30 at predetermined intervals such as intervals of at least every ⁇ /4.
- the preferred electrical lead 5 may be specially manufactured to include the shielded RF chokes 30 at predetermined intervals such as intervals of at least every ⁇ /4.
- RF chokes resist the flow of currents of certain frequencies and pass currents of certain relatively lower frequencies (the term "RF trap” is also commonly used).
- the shielded RF choke or chokes 30 will resist (and possibly entirely prevent) current flow at high frequencies such as the RF field frequencies of an MRI device, and will at the same time let the current pass at lower frequencies, e.g., the frequencies of the implantable device with which it is used.
- the possibility of the induction of current, and therefore production of heat, due to the RF field of the MRI is reduced (and possibly entirely prevented), while still allowing the transmission of signals from a generator 15 to a location 20 as shown in Figure 2.
- the segment of electrical wire 25 that is provided inside the location 20, such as an organ or other tissue does not include a shielded RF choke 30, and instead is preferably shorter than ⁇ /2 and therefore relatively safe.
- FIG 3 is a schematic diagram of an electrical lead 5 1 according to an alternate embodiment of the present invention that is similar to the electrical lead 5 except that it includes one or more shielded RF chokes 30' that, instead of using a single layer of shielding material 35, employ multiple layers of shielding material 35A and 35B for improved decoupling of the magnetic field.
- the electrical lead 5' includes multiple RF chokes 30 spaced at intervals as described.
- one end of the layer is electrically connected to the inductor 33 and the other end of the layer either floats or touches the insulating material, if present, surrounding the electrical wire 25.
- Figure 4 is a schematic diagram of an electrical lead 5" according to a third, further alternate embodiment of the present invention that is similar to the electrical lead 5 except that it includes one or more shielded RF chokes 30" in the form of inductors 33 ⁇ that each have a core 40 provided within the inductor 33.
- the core 40 inside each inductor 33 provides a higher inductance for a given resistance.
- a paramagnetic material such as, without limitation, aluminum or various plastic materials, is used to form the core 40.
- ferromagnetic materials should not be used for the core 40 to resist any attraction by the magnetic filed of the MRI.
- FIG. 5 is a schematic diagram of an electrical lead 45 according to a yet another alternate embodiment of the present invention.
- the electrical lead 45 is similar to the electrical lead 5 shown in Figure 1 in that it includes a plurality of segments of electrical wire 25.
- the electrical lead 45 in this embodiment includes one or more shielded RF chokes 47 each having the form of a toroidal inductor that preferably includes a torus-shaped coil 50 wrapped around a doughnut-shaped core 55.
- the shielded RF chokes 47 perform essentially the same function as the shielded RF chokes 30 described above as the shielded RF chokes 47 trap electromagnetic fields within the doughnut-shaped core 55 and resist the induction of currents as a result of external electromagnetic fields.
- the electrical lead 45 includes multiple shielded RF chokes 47 spaced at intervals as described above in connection with the shielded RF chokes 30.
- the shielded RF chokes 47 are used, there may be no need for a layer of shielding material (as in the shielded RF chokes 30, 30' and 30") as the electromagnetic field is trapped inside the core 55.
- FIG. 6 A is a schematic diagram of an electrical lead 60 according to still a further alternate embodiment of the present invention.
- the electrical lead 60 includes a plurality of segments of electrical wire 25' which, in this embodiment, each comprise a multiple conductor wire, preferably in the form of a flexible insulated multiple conductor wire or a coaxial cable.
- the electrical lead 60 is similar to the electrical lead 5 shown in Figure 1 as it includes a one or more shielded RF chokes 30 including an inductor 33 surrounded by layer of shielding material 35 as described above.
- the electrical lead 60 includes multiple shielded RF chokes 30 spaced at intervals as described above in connection with Figure 1.
- each inductor 33 of each shielded RF choke 30 is electrically coupled to each of the wires of one of the adjacent segments of electrical wire 25' and the opposite end of the inductor 33 of each shielded RF choke 30 is electrically coupled to each of the wires of the other of the adjacent segments of electrical wire 25'.
- an additional layer or layers of shielding material may be provided as shown in Figure 3
- a core 40 may be provided in the shielded RF choke 30 as shown in Figure 4
- a toroidal RF choke 47 as shown in Figure 5 may be used.
- FIG. 7 is a schematic diagram of an electrical lead 60' according to another alternate embodiment of the present invention that is similar to the electrical lead 60 shown in Figure 6.
- the electrical lead 60' differs from the electrical lead 60 in that, instead of a single shielded RF choke 30 being provided between adjacent segments of electrical wire 25', multiple shielded RF chokes 30 are provided between adjacent segments of electrical wire 25'. Specifically, as shown in Figure 7, one shielded RF choke 30 is provided for each conductor contained in the segments of electrical wire 25'.
- Figure 8 is a schematic diagram of an electrical lead 60" according to yet another alternate embodiment of the present invention that is similar to the electrical lead 60 shown in Figure 6 except that each shielded RF choke 30 is replaced by a toroidal shielded RF choke 47 as shown in Figure 5.
- Figures 9A and 9B are schematic diagrams of a electrical leads 65 A and 65B, respectively, according to still further alternate embodiments of the present invention.
- the electrical lead 65 A includes a plurality of segments of electrical wire 25' which each comprise a multiple conductor wire, preferably in the form of a flexible insulated multiple conductor wire.
- each conductor wire or each conductor therein may be, for example and without limitation, a coaxial wire or a triaxial wire.
- the electrical lead 65A includes a one or more alternative shielded RF chokes 67A that are preferably spaced at intervals as described above in connection with Figure 1.
- each shielded RF choke 67 A comprises a layer of shielding material 35 as described above that covers but is not in contact with the conductor portions 75 located between the adjacent segments of electrical wire 25', and a capacitor 70 provided between each such conductor 75 and the layer of shielding material 35.
- an inductor 33 is provided between each conductor 75 and the segment of electrical wire 25' that is electrically upstream (in terms of current flow) from the point at which the capacitor 70 is connected to the conductor 75.
- the capacitors 70 are tuned.
- the electrical lead 65 B shown in Figure 9B is similar to the electrical lead 65 A, except that in the electrical lead 65B, an inductor 33 is provided between each conductor 75 and the segment of electrical wire 25' that is electrically downstream (in terms of current flow) from the point at which the capacitor 70 is connected to the conductor 75.
- the capacitors 70 are short at relatively high frequencies (on the order of 100 MHz) and therefore no signal is transmitted by the electrical lead 65B, and therefore no signal is provided to the location 20 (such as the brain or some other organ or tissue within the body) shown in Figure 2.
- the inductors 33 may be wrapped together.
- Figure 10 is a variation of the embodiment shown in Figure 6 wherein a layer of insulating material 80, such as, without limitation, Teflon, polyethylene, nylon, rubber or pvc, is provided around the segments of electrical wire 25' and the shielded RF chokes 30 except for those areas that must remained exposed for proper operation of the implantable device with which the electrical lead 60 is to be used (as is known, some implantable devices, such as pacemakers, require one or more portions of the leads to be exposed so that an electrical connection or connections to the body can be made).
- the layer of insulating material 80 will provide further safety as charges may tend to accumulate at the edges of the layer of shielding material 35.
- the layer of insulating material 80 is not limited to the electrical lead 60, but may also be used with the other embodiments shown herein. In addition, when the electrical lead 60 (or the other electrical leads described herein) are used with an implantable device, the layer of insulating material 80 may also cover the generator 15 ( Figure 2).
- Figure 1 IA shows the normalized induced current on a regular wire and a lead 5.
- Figure 1 IB shows the SAR distribution on the surface of the regular and the lead 5. From these simulations, it is obvious that the lead 5 is able to separate the wire into two wires.
- gel phantom experiments were performed on a regular pacemaker and a pacemaker including an electrical lead 5.
- the gel phantom setup is shown in Figure 12 and includes a temperature probe 1 located at the tip of the pacemaker lead in each case and a reference probe 2.
- the gel phantom setup for each pacemaker (regular and safe, i.e., including the lead 5) shown in Figure 12 was subjected to MRI scanning and profiles of the temperatures measured by the probes are shown in Figure 13. As can be seen, the pacemaker that included the lead 5 experienced significantly less heating.
- burst switch 10 is awakening a processing unit 15. It should be appreciated that the burst switch 10 may be utilized to awaken any type of electronic device that is capable of entering an inactive, sleep state. Additions, deletions, substitutions, and other modifications can be made without departing from the spirit or scope of the present invention. Accordingly, the invention is not to be considered as limited by the foregoing description but is only limited by the scope of the appended claims.
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US67741805P | 2005-05-04 | 2005-05-04 | |
PCT/US2006/017362 WO2006119492A2 (en) | 2005-05-04 | 2006-05-04 | Improved electrical lead for an electronic device such as an implantable device |
Publications (3)
Publication Number | Publication Date |
---|---|
EP1878091A2 true EP1878091A2 (en) | 2008-01-16 |
EP1878091A4 EP1878091A4 (en) | 2011-01-26 |
EP1878091B1 EP1878091B1 (en) | 2017-02-22 |
Family
ID=37308740
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP06759133.9A Active EP1878091B1 (en) | 2005-05-04 | 2006-05-04 | Improved electrical lead for an electronic device such as an implantable device |
Country Status (6)
Country | Link |
---|---|
US (4) | US7561906B2 (en) |
EP (1) | EP1878091B1 (en) |
CN (1) | CN101553165B (en) |
CA (1) | CA2606824C (en) |
ES (1) | ES2623366T3 (en) |
WO (1) | WO2006119492A2 (en) |
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CN101553165B (en) | 2011-05-18 |
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US20090254152A1 (en) | 2009-10-08 |
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